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(Asbestos filter (Seitz filter): They are disposable, single-use discs made up of

asbestos (magnesium trisilicate). It is supported on a perforated metal disc within a metal

funnel (Fig. 74). It is then fitted on to a sterile flask through a silicone rubber bung. The fluid

to be sterilized is put into the funnel and flask is connected to the exhaust pump. After

completion of fitration, the filter is discarded and the entire unit sterilized. The pore size of

iters range from 0.01 to 5 microns.

Sintefed glass filters (fritted glass filter/morton filters): Borosilicate glass is finely

Powdered in a ball mill and packed into disc moulds and heated until suitable adhesionTakes place between the granules. The sintered discs are finally fused into funnels of a

Sutable size and shape (Fig. 7.5). Sintered glass filters are available in several differentOrosties but for filtration sterilization a number or grade 5 or 5 on 3 must be used. They

a lowadsorptive property and can be cleaned easily. They are brittle and expensive andhave a small area of filtration.


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Sintered dlsc

FunnelAsbestos pad(Flterlng medla)

Wing nut

Perforated plate

Fig. 7.5: Sintered glass filterFig.7.4: Seitz filter

(ii) Filter candles (ceramic/Berkefield filter): These are manufactured in different

grades of porosity and have been used widely for purification of water for industrial and

drinking purposes. They are made of either porous porcelain or kieselguhr. They are usual

encountered as cylindrical candles with comparatively thick walls (Fig. 7.6). These are depth

filters with cellular walls and are available in various sizes.

Fig.7.6: Filter candles

The filter is fixed to the filter assembly and placed in a mantle. The liquid to be filtered is

poured into the mantle where vacuum forces it through the filter. After filteration, filter

candle is removed from the assembly and filterate istransferred toa sterile container.

These filters are inexpensive and available in different sizes. They are easily clogged and

blocked and require high pressure for filtration.


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av) Membrane filter (millipore/ultra filter): These are made up of various types of

cellulklose and cellulose esters. They are 150 um thick and contain millions of microscopic

steri

pores ranging fro

rilization are 045 um t 0.02 pm (Millipore grade, HA) or 0.22 m t 0.02 um (Milliporede, GS), particularly for very small bacterial contaminants. They are sterilized by

from 0.01 to 10 um in diameter. The pore sizes most often used for

utoclaving, in the holder or packed between thick flter pads to prevent curling. They are5o available at ready sterilised form (by ethylene oxide or ionizing radiation), Membrane

Fiters are supported on a rigid base of perforated metal, plastic or coarse sintered glassEia. 7.7). The HA grade filiters are approximately 65 ml/min./sq.cm. (GS 22 ml/min/sq.cm)

with a differential pressure of 70 cm mercury across the membrane.

-Funnel

Filter

Filter holder-Cotton

To suction pump

Flask-Fltrate (Sterile)

(a) Components of filter (b) Membrane filtration assembly

Fig. 7.7: Membrane filter

Advantages of membrane filters are as follows

1 All microorganisms are separated by process of sieving.

2 Membranes have a high and uniform porosity permitting a rapid rate of filtration.

3. Membranes are disposable. Hence, there is no cross contamination between filtered

products.

4. Adsorption is very less.Disadvantages of membrane filters are as follows:

Prefilter is used before the membrane filterto avoid clogging and breaking.

They have less chemical resistance to certain organic solvents such as chloroform,

sterilityand for the preparation of solutions for parenteral use. They are also been

ketones and esters.

mbrane filters are routinely used in water purification and analysis, sterilization,

d for the identification and enumeration of microorganisms from water samples anaother materials.


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STERLT INDIGATORS

It is essential that strict controls are carried out on products to be labelled 'sterile. Suc

controls must then ensure, the absence of viable microorganisms from these product

There are basically two types of controls:

L Controls on the process of sterilization ie. sterilization monitors or sterilization

indicators.

2. Sterility testing of the products.

Monitoring of the sterilization process can be achieved by the use of physical, chemicor biological indicators of the sterilization performance.

1. Physical indicators:

Moist heat: A master process record (MPR) is prepared as part of the validationprocedure for a particular autoclave and for each specified product and loadconfiguration. This may then be used as a reference for the process record

btained from a single thermocouple placed in a strategic part of each load (batdprocess record, BPR). The MPR should be checked at annual intervals andwhenever significant changes occur in the BPR when compared with the MPRMicroprocessor controlled sterilization cycles are now a part of modemautoclaves. Pressure is measured by pressure gauges or through pressutransducersDry heat: In dry heat sterilization processes, a temperature record chart ismadeoeach sterilization cycle and is compared against a master temperature record.GD Radio sterilization: A plastic dosimeter gives an accurate measure of the radiatio"dose absorbed and is considered to be tl.2 best technique currentlyavailablethe radio sterilisation process.

0) Gaseous methods: For gaseous sterilization procedures, elevated temperatuare monitored for each sterilization cycle by temperature probes and routinee


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tests are performed to ensure gas-tight seals. Gas concentration is measureaindependently of pressure rise, often by reference to the weight of gas used.Pressure and humidity measurements are recorded.Filtration: Bubble point pressure test is a technique employed for determining the()pore size of filters and may also be used to check the integrity of certain types offilter devices immediately after use. The principle of the test is that the filter is

soaked in an appropriate fluid and pressure is applied to the filter. The pressuredifference when the first bubble of air breaks away from the filter is equivalent tothe maximum pore size. When the air pressure is further increased slowly, there is

general eruption of bubbles over the entire surface. The pressure difference is

equivalent to the mean pore size.

2 Chemical indicators:

Chemical monitoring of a sterlization process is based on the ability of heat, steamsterilant gases and ionizing radiation to alter the chemical or physical characteristics of a

variety of chemical substances.

Browne's tubes: The most commonly used chemical indicators for heat processes

are Browne's tubes. These are small sealed tubes containing a reaction mixture and

an indicator. Exposure to high temperature completes the reaction producing a

change in the colour of the indicator (Table 7.5). All four types change from red

through yellow brown to green, the latter colour only being achieved after a

specified time at the given temperature.

Table 7.5: Types of Browne's tubes

Colour of indicatorTemperature(C)

Method of sterilizationBrowne'stube

ype Moist heat 126 Black spot

ype High vacuum moist heat 130 or more Yellow spot

ype II Dry heat 160 Green spot

ype IV |Dry heat infra-red conveyoroven 180 Blue spotCGi) Witness tubes: Witness tubes consist of single cnystalline substances of known

melting point contained in glass tubes e.g. sulphur (115 C), succinic anhydride

(120C), benzoic acid (121") etc. A dye may be included to show more clearly thatthe crystals have melted. Such a device only indicates that a certain temperaturehas been reached. Exposure time can be calculated by putting the crystals in oneend of an 'hour-glass' tube, the volume of the crystals and the diameter of theconstriction of the tube being adjusted so that the time for transfer of the melt is

the same as that required for the sterilisation at the required temperature.


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(i) Heat-sensitive tape: Heat-sensitive tape is used quantitatively in the Bowie-Di

test. This is a test to determine that all air has been removed from dressings and

that subsequent steam penetration has been even and rapid. The tape is placed

suitably wrapped at the centre of a test pack. All the bars on the tape shoul

change colour to demonstrate full penetration of the steam.

(iv) Royce sachet: The Royce sachet is a chemical indicator for ethylene oxide

sterlization. This consists of a polythene sachet containing magnesium chloride,

HCI and a bromophenol blue indicator. A given concentration-time exposure to

ethylene oxide results in the formation of ethylene chlorohydrin and a colour

change from yellow to purple.

(v) Chemical dosimeters: Chemical dosimeters give an accurate measure of the

radiation dose absorbed and are considered to be the best technique currently

available for controlling radiation sterilization. Qualitative indicatorsS made of

radiosensitive chemicals impregnated in plastic are also available. The indicator

changes from yellow to red during irradiation.

3. Biological indicators:

Biological indicators consist of a suitable organism deposited on a carrier and are

distributed throughout the sterilizer load. At the end of the sterilization process, the units

are recovered and cultured to determine the presence or absence of survivors. The

biological indicator measures sterilization processes directly and is able to integrate all

sterilization parameters. The selected organism should possess high and reproducible

resistance to the sterilizing agent, should be genetically stable, readily characterizable and

non-pathogenic. The viability of the organisms, the storage conditions before use and the

incubation and culture conditions after sterilization must be standardized for the results. The

organisms used as biological indicators are usually resistant bacterial spores (Table 7.6).

Table 7.6: Biological indicators formonitoringsterilization processes

Sterilizationprocess Species D-value

|BacillusstearothermophilusClostridium sporogenes

Bacillus subtilis var. nigerBacillus subtilis var. niger

1.5 min

0.8 min

5-10 min

2.5 min

Autoclave at 121°C

Dry heat at 160°C

Ethylene oxide at 600 mg/lit.

Temperature 54 C 60% - relative

humidity)Tonizing radiation

Membrane filter (0.45 um pore size)

Bacillus pumilus

Serratia marcescens3 kGy (0.3 M rad)

Membrane filter(0.22 um poresize) Pseudomonas diminuta


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